Zyno Medical Z-800 User manual

Z-800 Instructions for Use. 1/69
P/N 800-600-01-08 Rev 08/10
Z-800 Infusion Pump
INSTRUCTIONS FOR USE
Revised 08/2010
Zyno Medical LLC
9 Tech Circle
Natick, MA, 01760
1-508-650-2008
Fax: [phone]
Web: www.zynomedical.com

Z-800 Instructions for Use. 2/69
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WARNING:
Only use Zyno Medical provided IV sets with the Z-800 pump. There are risks associated
with using any IV sets other than Zyno Medical sets with this device. Zyno’s warranty for
its device will be null and void and Zyno will assume no responsibility for any incidents
that may occur if the device is not utilized strictly in accordance with its product labeling.
SAFETY STANDARD
The Z-800 infusion pump meets all safety standards for medical electrical devices,
corresponding to IEC 60601-1 and IEC 60601-2-24.

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TABLE OF CONTENTS
INTRODUCTION
About the Device ……………………………………………...………………………..
4
Features …………….…………………………………….……………………………..
5
Symbols ...........................................................................................................................
6
GETTING STARTED
Warnings & Cautions........................................................................................................
7
Device Description ...........................................................................................................
9
Installation Procedure …………………………………………………………………...
12
Preparing An Infusion …………………………………………………………………..
13
Loading Primary Administration Set …………………………………………………...
14
Continuous Mode Infusion …………………………………………………….………..
16
Time/VTBI Programming ………………………………………………………………
24
Infusion Complete ………………………………………………………………………
26
10 STEP Mode Infusion ……………………………………………………….………..
27
TPN Mode Infusion …………………………………………………...………………...
29
Intermittent Mode..............................................................................................................
31
Blood Mode.......................................................................................................................
34
Prime IV Set Using PRIME Key......................................................................................
36
Powering Off ...................................................................................................................
39
Changing the Primary Solution Container .......................................................................
40
Changing & Reloading an IV Set During Infusion ..…...……..………..……………….
41
Protocol Mode Infusion………………………………………………………………….
42
Save Infusion Parameters as a Protocol …..…………………...…………...…………...
43
ALARMS AND TROUBLESHOOTING
Definition ……………......................................................................................................
44
Alarms ..............................................................................................................................
45
Warnings ………………..................................................................................................
46
Errors ………………........................................................................................................
48
MAINTENANCE
Specifications ...................................................................................................................
48
Configurable Settings .......................................................................................................
50
Storage ..............................................................................................................................
55
Battery Care and Maintenance ..…...................................................................................
56
Cleaning ……...................................................................................................................
59
Inspection Requirements...................................................................................................
60
Service Information ..........................................................................................................
61
Warranty............................................................................................................................
62
APPENDIX
Alarm Testing Procedure ..................................................................................................
63
Approved Administration Sets .........................................................................................
67

Z-800 Instructions for Use. 4/69
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INTRODUCTION
ABOUT THE DEVICE
The Z-800 Infusion pump is intended to provide accurate
delivery of parenteral fluids, blood and blood products to a
human patient when administered by a qualified health care
professional.
User Qualification
The Z-800 infusion pump is intended for use at the direction
or under the supervision of licensed physicians or certified
healthcare professionals who are trained in the use of the Z-
800 infusion pump and the administration of parenteral fluids
and drugs, blood and blood products. This training should
emphasize patient safety and prevention of error.
This document provides directions for use of the Z-800
infusion pump. To ensure safe usage, please read the entire
instruction manual before using the device.
The Z-800 infusion pump must only be operated utilizing
Zyno Medical’s proprietary administration sets. The sets are
designed for use with the Z-800 pump as well as for gravity-
flow stand-alone use. For specific administration set
instructions, refer to the Directions For Use provided with the
set. For priming and loading instructions, refer to ―Loading a
Primary Administration Set‖ and ―Loading a Secondary
Administration Set‖ sections of this document.
Contraindication: None known.

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INTRODUCTION
FEATURES
Flow Rates
The Z-800 flow rate range is from 1 to 999 ml/h.
Free Flow Protection
Z-800 Pump has a built in free flow clamp to prevent
inadvertent free flow when the set is loaded in the pump.
WARNING: Some Z-800 IV sets configurations do
NOT have set based free-flow protection. Make sure to
close roller clamp before removing administration set
from Z-800 pump.
Occlusion Pressure
The Z-800 Pump provides 14 levels adjustable
downstream occlusion alarm thresholds between 4 psi to
30 psi.
Secondary Infusions
Secondary infusions may be delivered at a specified
secondary delivery rate and secondary volume-to-be-
infused (VTBI) independent of the primary infusion
parameters. When secondary VTBI is greater then zero,
the pump will always execute secondary infusion first.
Automatic changeover occurs to the primary infusion
parameters when the secondary infusion is complete. A
Zyno Medical proprietary primary administration set
with a back check valve must be used.
System Configuration
The system configuration mode provides the ability for
qualified personnel to customize device settings.
Tamper Resist
The Tamper Resist feature provides a quick, one touch
lockout of the front keypad.
Volume-To-Be-Infused
(VTBI)
The volume-to-be-infused (VTBI) range is from 1 to
9999 ml in 1 ml increments.

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INTRODUCTION
SYMBOLS
Canadian and U.S. Certification Mark: Products bearing this
mark have been tested and certified in accordance with
applicable U.S. and Canadian electrical safety and performance
standards (CSA C22.2 No. 601.1, UL 2601-1 and IEC 60601-2-
24).
Electrical Shock Protection Rating: Type BF.
IPX1
Protection against fluid ingress: Drip Proof.
Attention: Refer to accompanying documentation.
Rx Only
Federal (U.S.A) law restricts this device to sale by or on the
order of a physician.
Ground Pole. Potential Equalization Conductor (PEC). Note: If
the integrity of the PEC or Hospital Earth System is in question,
operate the instrument using internal battery power.

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GETTING STARTED
WARNINGS & CAUTIONS
The following Warnings and Cautions should be strictly followed to avoid harm to patients
and pump operators:
WARNING: Zyno Medical assumes no responsibility for incidents that may occur
if its product is not used in accordance with its product labeling.
WARNING: Only use Zyno Medical provided IV sets in the Z-800 pump.
WARNING: The Z-800 pump operation is strictly limited to trained operators
whose competency in safe Z-800 pump operation and safe IV therapy practices has
been tested and proven.
WARNING: Make sure the pump is stable by fastening securely to an IV pole, or
resting on a flat surface. IV poles vary in quality and stability. Avoid fastening the
pump too high on the pole, and test for stability before using.
WARNING: Prior to use, always verify the proper function of the display, audible
and visual alarms.
WARNING: Verify there are no kinks in the tubing when loading into the pump.
WARNING: Always read and follow the instructions that accompany the fluid
container and IV administration sets you are using. Carefully follow the
instructions in this document for loading, removing, and reloading the IV set.
Adjust the pumping section of the IV set every 24 hours, and replace the IV set at
least every 72 hours.
WARNING: To prevent free flow, make sure to load the IV set in the pump before
connecting the IV set to patient.
WARNING: To prevent free flow, make sure to disconnect the IV set from patient
before unloading the IV set from the Z-800 pump.
WARNING: Disconnect IV set from the patient before purging air bubbles out of
IV tubing.
WARNING: Some Z-800 IV sets configurations do NOT have set based free-flow
protection. Make sure to close roller clamp before removing administration set from
Z-800 pump.
WARNING: Do not over-program VTBI. Program the actual amount of the fluid
in the IV bag.

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GETTING STARTED
WARNINGS & CAUTIONS (Continued)
CAUTION: Please read the entire contents of this manual before using the Z-800 pump.
CAUTION: USA Federal and Canadian laws restrict this device to sale by or on the
order of a physician.
CAUTION: No user serviceable parts inside. Refer all service, repair, and calibration
to qualified technical personnel. Do not make unauthorized modifications.
CAUTION: To avoid mechanical or electronic damage, do not steam, autoclave or
immerse the pump in any fluids or cleaning solutions, and do not spray such fluids
directly on the pump. Always disconnect electrical power cord from outlet before
cleaning to prevent electrical shock. The IPX1 rating means that the pump is protected
against vertical dripping water.
CAUTION: Do not attempt to infuse two fluids simultaneously using the Z-800
infusion pump.
CAUTION: Operating Z-800 infusion pump near equipment that radiates high-energy
radio frequencies (electrosurgical/cauterizing equipment, portable radios, cellular
telephones, etc.) may cause false alarm conditions. If this happens, reposition the
device away from the source of interference or use an appropriate clinical alternative.
CAUTION: Always verify displayed infusion parameters (Primary Rate, Primary
VTBI, Secondary Rate, Secondary VTBI) against prescription before starting infusion.
GETTING STARTED
WARNING: After starting an infusion, make sure drops are falling in the drip
chamber. If no drops are falling, make sure the roller clamp is open. If the roller clamp
is open and still no drops are falling, replace and dispose of the IV administration set.
WARNING: The air detector cannot recognize the introduction of air at 3-way
stopcocks, infusion ports, and other lines/tubes below the pump.
WARNING: Do not operate this device in the presence of flammable anesthetics
mixture with air or oxygen or nitrous oxide.
WARNING: Do not expose Z-800 pump to X-Rays, gamma rays or other radiation, or
to strong electric or magnetic fields.
WARNING: The factory default settings should be used unless qualified clinical
personnel determine that other customized settings are appropriate and safe.

Z-800 Instructions for Use. 9/69
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DEVICE DESCRIPTION
Pump Front View –Door Closed

Z-800 Instructions for Use. 10/69
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GETTING STARTED
DEVICE DESCRIPTION (Continued)
Pump Front View - Door Open

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GETTING STARTED
DEVICE DESCRIPTION (Continued)
Pump Back View

Z-800 Instructions for Use. 12/69
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GETTING STARTED
INSTALLATION PROCEDURE
UNPACK THE PUMP
The Z-800 infusion pump is supplied complete with
A standard detachable, listed/certified IEC Hospital
Grade electrical cord.
Pole Clamp pre-mounted at 45 degree angle to the
pump.
Instruction for Use.
1. Remove Pump module from its carton.
2. Inspect the pump.
3. Check to ensure pump door operates freely.
4. Check for any loose parts.
NOTE: If any of the following conditions are observed,
the Z-800 pump must be removed from use and inspected
by qualified personnel:
Look for any signs of physical damage from
shipping.
LED segments are not illuminated during system
power-on self-test.
Indicator lights do not illuminate.
Audio tune does not sound.
Main Display does not appear backlit, appears
irregular, or has evidence of a row of pixels not
functioning properly.
MOUNT PUMP TO IV POLE
1. Attach the pump to an IV pole by turning the knob on
the pole clamp clockwise, or place the pump on a flat,
stable surface.

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GETTING STARTED
PREPARING AN INFUSION
Powering On the System
1. Connect the Z-800 Pump power cord to an AC
power source.
2. Press and hold the ON/OFF key on the Z-800
Pump for 2 seconds.
3. System self-test begins:
The diagnostics test causes all LED display
segments and Status indicator lights to
illuminate briefly.
The Power Indicator illuminates.
An Audio tune sounds.
4. The Main Display shows the Zyno Medical Logo,
Pump Serial Number and Software Version for 2
seconds and pump safety configurations for 2
seconds during the system power-on self-test.
5. Upon completion of system power-on self-test, A
New Infusion prompt screen will be displayed
prompting user to choose either resume a
previously interrupted infusion or start with a new
infusion.
6. If the user elects to resume the previously
interrupted infusion, the pump will enter into the
Programming screen of the previous selected
infusion mode and with the previous infusion
parameters populated.
7. If the user elects to start a new infusion, the pump
will prompt user to select the Infusion Mode. Upon
user selection, the pump will enter into the Infusion
Programming screen of the selected Infusion Mode
with all infusion parameters reset to zero. The user
may choose one of the following infusion modes:
Continuous Mode with Rate/VTBI parameters
Continuous Mode with Time/VTBI parameters
10 Step Mode
TPN Auto Ramp Mode
Stored User-Defined Protocols

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GETTING STARTED
LOADING PRIMARY ADMINISTRATION SET
Preparing the Primary Solution Container
Prepare the primary solution container in accordance with
the manufacturer’s directions for use.
Preparing the Primary Administration Set
Use only Zyno administration sets (refer to Approved
Administration Sets section for a list of compatible sets).
Open the administration set package, remove the set and
close the roller clamp.
WARNING: Some Z-800 IV sets configurations
do NOT have set based free-flow protection feature.
Make sure to close roller clamp before removing
administration set from Z-800 pump.
Steps 6 & 7
Loading Primary Administration Set
1. Insert set spike into prepared fluid container
following accepted clinical procedure, and hang the
container approximately 20 inches above the Pump.
2. Fill the drip chamber to 1/3 full by squeezing it.
3. Open the roller clamp slowly, to prime tubing and
clear air from the luer lock at the patient (distal) end
of the administration set.
4. Close the roller clamp.
5. Open the pump door.
6. Using a fingertip, firmly push tubing into the gap of
Air-in-Line Sensor. (See picture ―Steps 6 & 7‖)
7. Align tubing on top of the gap of Free Flow Clamp
(Do not force tubing into the Free Flow Clamp).
The pump will load the tubing into the Free Flow
Clamp automatically when the pump door is closed.
8. Using a fingertip, firmly push tubing into the gap of
the tubing guides on the pumping fingers. (See
picture ―Step 8‖)
9. Using a fingertip, firmly push tubing into the gap of
upper tubing guides. (See picture ―Step 9‖)
10. Close pump door by pushing down the pump door
handle (See picture ―Step 10‖)
11. Connect the administration set to the patient’s
injection site.
Step 8
Step 9
Step 10

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GETTING STARTED
LOADING PRIMARY ADMINISTRATION SET
(Continued)
LOADING IV SET INTO Z-800 PUMP
WARNING: Some Z-800 IV sets configurations do NOT have set based free-
flow protection feature. Make sure to close roller clamp before removing
administration set from Z-800 pump.

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GETTING STARTED
CONTINUOUS MODE—PRIMARY INFUSION
Change Primary Flow Rate
Use Up/Down Arrow keys to highlight Pri RATE. Use
Data Entry keys to modify the corresponding digits of Pri
RATE value.
Example: Programming Pri RATE = 125 mL/h
1. Use Up/Down Arrow keys to highlight Pri RATE.
2. Press the 100’s Up data entry key once to increase
the 100’s digit of Pri RATE to 100.
3. Press the 10’s Up data entry key twice to increase
the 10’s digit of Pri RATE to 20.
4. Press the single digit’s Up data entry key five times
to increase the single digit of Pri RATE to 5.
Primary Infusion Programming Screen
User may choose to program the continuous infusion either
in RATE/VTBI or TIME/VTBI. The primary infusion
programming screen contains the following display areas:
1. Status Bar: The Status Bar displays current operating
mode; current pump state; and volume infused.
CONT: Indicate the current application mode is
Continuous Mode Operation.
SET: Indicate the current pump state is
Programming state.
VINF: Volume Infused during the current infusion.
2. Infusion Parameters: -- Primary Flow Rate and
Primary Volume To Be Infused.
Pri RATE: Primary Flow Rate.
Pri VTBI: Primary VTBI.
3. Soft Keys: Allows user to access pump configuration
and secondary infusion programming screen.
CONFIG: Access configurable settings.
SEC: Access secondary infusion programming.
Up/Down Arrows: Select parameter items.
WARNING: Do not over-program VTBI. Program the actual amount of IV bag fluid.

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GETTING STARTED
CONTINUOUS MODE—PRIMARY INFUSION (Continued)
Change Primary VTBI
Use Up/Down Arrow keys to highlight Pri VTBI. Use
Data Entry keys to modify the corresponding digits of Pri
VTBI value.
Example: Programming Pri VTBI = 250 ml
Use Up/Down Arrow keys to highlight Pri VTBI.
Press the 100’s Up data entry key twice to increase
the 100’s digit of Pri VTBI to 200.
Press the 10’s Up data entry key five times to
increase the 10’s digit of Pri VTBI to 50.
Start Primary Infusion
Verify displayed infusion parameter entries (Primary Rate,
Primary VTBI). If a clamp is engaged, remove the clamp.
Press RUN/STOP key to start the infusion.
Stopping and Resuming a Primary Infusion
Press RUN/STOP key during infusion. The infusion will be
paused. The PAUSE screen will be displayed.
From the PAUSE state, press RUN/STOP key to resume
infusion.
Titrate Flow Rate or VTBI During a Primary Infusion
From the PAUSE screen, press PROG soft key; the pump
will display primary infusion programming screen. User is
then able to modify the primary RATE and primary VTBI
parameters.
RUN/STOP key

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GETTING STARTED
CONTINUOUS MODE--PRIMARY INFUSION (Continued)
Primary Infusion Execution
During an infusion, the two Infusion Status Indicator LEDs
will illuminate in green and toggle once per second.
The primary infusion execution display contains the
following contents:
Status Bar: The Status Bar displays the current operating
mode; current pump state; and volume infused.
CONT: Continuous Mode Operation.
RUN: Pump RUN state.
TL: Time Left in HH:MM format for the current
infusion.
Infusion Parameters: Current infusion parameters.
Pri RATE field displays primary flow rate.
Pri VTBI field counts down to show remaining VTBI.
Pri VINF field counts up to show volume infused.
3 minutes before infusion completes, a short audio prompt
tone will sound twice. Along with the audio prompt, the
screen will display ―INFUSION NEAR END‖ message.
This alert will repeat every 5 seconds until the infusion is
complete.
At completion of the infusion, an audio prompt sounds.
Along with the audio prompt, the screen will display
―INFUSION COMPLETE – KVO‖. This alert will repeat
every 5 seconds until user intervention. During KVO state,
the Flow Rate Indicator will change to display KVO flow
rate.
Clearing the Volume Infused During a Primary Infusion:
Pause the primary infusion by pressing the RUN/STOP key
during infusion. Exit the PAUSE screen by pressing the PROG
soft key. From the Primary SETUP screen, press the CLR soft
key. An audio/visual prompt will be presented requesting user
confirmation of clearing VINF. Press the OK soft key to
confirm. The VINF field will be reset to 0 ml. A confirmation
screen will be displayed briefly indicating VINF has been
cleared. From the ―Clear VINF?‖ screen, user can press the
QUIT soft key to abort the action.
NOTE: The VINF field will record cumulative infusion
volume infused unless cleared by pressing the CLR soft key or
turning the pump off/on and starting a new infusion.

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GETTING STARTED
LOADING A SECONDARY ADMINISTRATION SET
1. Program and start the primary infusion using a check-
valve primary administration set, as previously
described.
2. Open a secondary administration set package, remove
the set and close the set roller clamp.
3. Insert set spike into a prepared fluid container and hang
secondary container, following accepted clinical
procedures.
4. Fill the drip chamber to 1/3 full.
5. Open a secondary set and prime the set. Close the set
roller clamp.
6. Attach a secondary set to the upper injection site on the
primary set.
7. Ensure no air bubbles are present in the line.
8. Hang the secondary fluid container at least 8 inches
above the primary solution container.
WARNING: Some Z-800 IV sets configurations do
NOT have set based free-flow protection. Make sure to
close roller clamp before removing administration set
from Z-800 pump.
WARNING: The bottom of the secondary
solution should be at least 19” above the top of the
pump.
WARNING: A minimum height differential
between primary and secondary solutions of eight inches
is essential for the safe operation of a primary/secondary
infusion.

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GETTING STARTED
CONTINUOUS MODE--SECONDARY INFUSION
Access Secondary Infusion Programming Screen
From the Continuous Mode Primary Infusion
Programming screen, Press SEC soft key to access the
secondary infusion programming screen.
Secondary Infusion Programming Screen
Similar to the primary infusion programming screen, The
secondary infusion programming screen contains the
following display areas:
1. Status Bar: The Status Bar displays current
operating mode; current pump state; and volume
infused.
CONT: Continuous Mode Operation.
SET: Setup pump state.
VINF: Volume Infused for the current
infusion.
2. Infusion Parameters: Secondary Flow Rate and
Secondary Volume To Be Infused.
Sec RATE: Secondary Flow Rate.
Sec VTBI: Secondary VTBI.
3. Soft Keys: Allow user to access pump configuration
and primary infusion programming screen.
CONFIG: Access pump configuration.
PRI: Access primary infusion programming.
Up/Down Arrows: Select parameter items.